Is a technical assessment required for my proposed variation?

For a variation to be processed without a technical assessment (Item 12), all risk areas must be supported by solely referencing another registered product (reference product). Applicants seeking to rely on a reference product should explain the reasons why the reference product supports the variation. This should include how the risks are equivalent between the two products including:

similarity in instructions for use

the active constituent and its concentration

the formulation type.

Limits on use (data protection): Where there are limits on use of information on the reference product written consent from the authorising party is required when access to the information is necessary to determine the application.

Where the reference product does not fully support all risk areas or the product is subject to limits on use and additional data is being provided to satisfy the safety, efficacy or trade criteria these applications should be lodged as Item 14 applications.

Which application form do you need?

The proposed variation is to a re-entry or handling instruction for:

Application guidance

Specific information on completing this application form is provided below. Once you are familiar with the content you can proceed to ‘Start an application’ at the button below.

Please note: the fees referenced in this tailored guidance take effect from 1 July 2020. For a list of fees and charges up to 30 June 2020, please view the timeframe and fees section on our website.

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The Australian Pesticides and Veterinary Medicines Authority acknowledges the traditional owners and custodians of country throughout Australia and acknowledges their continuing connection to land, sea and community. We pay our respects to the people, the cultures and the elders past, present and emerging.